Circulatory Support Device for Toddlers/Small Children

幼儿/幼儿循环支持装置

• 批准号: 6793068
• 负责人: JAMES F. ANTAKI
• 金额: $ 19.97万
• 依托单位: LAUNCHPOINT TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-15 至 2008-11-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6793068
• 关键词: auxiliary heart prosthesis; biomaterial compatibility; biomaterial development /preparation; cardiovascular disorder; circulatory assist; clinical research; congenital heart disorder; disease /disorder model; heart ventricle; hemodynamics; human subject; mathematical model; medical implant science; model design /development; pediatrics; shear stress; sheep

DESCRIPTION (provided by applicant): The overall goal of this application is to develop a safe, reliable, and biocompatible ventricular assist device (VAD) for toddlers/small children, between 15 and 35 kg (two to twelve years of age). Treatment options for this population, typically suffering from ventricular failure due to congenital and acquired heart disease, remain very limited in spite of the success of ventricular assistance in adults. The "Toddler VAD" (WAD) will utilize a centrifugal pump design with blood-lubricated bearings, optimized to minimize blood trauma and thrombosis. The device will be fully implantable, and capable of providing extended support (3 months). This project represents a collaborative effort between LaunchPoint, LLC, the University of Pittsburgh (UoP), and Children's Hospital of Pittsburgh (CHP). Collectively our consortium has a substantial expertise in cardiovascular bioengineering, computational fluid dynamics (CFD), blood damage modeling, control theory, electromagnetics, motor development, biocompatibility, and biorheology. We will specifically leverage technology and protocols accumulated through prior development of MedQuest HeartQuestTM and StreamLiner VAD to facilitate development of the TVAD. This application is further enhanced be the combined clinical experience of Drs. Robert Kormos, Bradley Keller, and Steven Webber who are internationally respected for pediatric cardiac care. This Phase-I project is scheduled for twelve months, and will culminate in three in vivo studies in juvenile sheep to demonstrate hemodynamic performance, safe operation, and basic biocompatibility. This will be accomplished through the flowing specific aims: Aim 1: Refine blood damage models using a novel blood shearing instrument (BSI) and state-of-the art biocompatibility assays. Aim 2: Design rotary blood pump with optimized hemodynamics utilizing CFD analysis and enhanced blood damage models. Aim 3: Fabricate and test TVAD prototype for pressure-flow measurement (H-Q curves), heat generation, and bearing performance. Aim 4: Conduct in vitro biocompatibility experiments with TVAD prototype. Aim 5: Conduct three short-term in vivo experiments to demonstrate basic hemodynamic performance and biocompatibility. Aim 6: Document Phase I feasibility to FDA standards. Our commercial partner, MedQuest Products (Salt Lake City, UT) is committed to collaborate with us through a subsequent Phase-II effort to ultimately bring this product to market.

描述（由申请人提供）： 该应用的总体目标是为体重 15 至 35 公斤（2 至 12 岁）的幼儿/幼儿开发一种安全、可靠且生物相容的心室辅助装置 (VAD)。尽管成人心室辅助取得了成功，但针对该人群（通常因先天性和后天性心脏病而患有心室衰竭）的治疗选择仍然非常有限。 “幼儿 VAD”(WAD) 将采用带有血液润滑轴承的离心泵设计，经过优化可最大限度地减少血液损伤和血栓形成。该设备将完全植入，并能够提供长期支持（3 个月）。 该项目是 LaunchPoint, LLC、匹兹堡大学 (UoP) 和匹兹堡儿童医院 (CHP) 之间的合作成果。总的来说，我们的联盟在心血管生物工程、计算流体动力学 (CFD)、血液损伤建模、控制理论、电磁学、运动发育、生物相容性和生物流变学方面拥有丰富的专业知识。我们将专门利用之前开发 MedQuest HeartQuestTM 和 StreamLiner VAD 积累的技术和协议来促进 TVAD 的开发。博士们的综合临床经验进一步增强了该应用。罗伯特·科莫斯 (Robert Kormos)、布拉德利·凯勒 (Bradley Keller) 和史蒂文·韦伯 (Steven Webber) 在儿科心脏护理方面享有国际声誉。 该第一阶段项目计划持续十二个月，最终将在幼年羊身上进行三项体内研究，以证明血流动力学性能、安全操作和基本生物相容性。这将通过以下具体目标来实现： 目标 1：使用新型血液剪切仪器 (BSI) 和最先进的生物相容性测定来完善血液损伤模型。目标 2：利用 CFD 分析和增强的血液损伤模型设计具有优化血流动力学的旋转血泵。目标 3：制造并测试 TVAD 原型，用于压力流量测量（H-Q 曲线）、发热和轴承性能。目标 4：使用 TVAD 原型进行体外生物相容性实验。目标 5：进行三个短期体内实验以证明基本的血流动力学性能和生物相容性。目标 6：记录符合 FDA 标准的第一阶段可行性。 我们的商业合作伙伴 MedQuest Products（犹他州盐湖城）致力于通过后续的第二阶段工作与我们合作，最终将该产品推向市场。

项目成果

In-vitro Evaluation of Ventricular Cannulation for Rotodynamic Cardiac Assist Devices.

旋转动力心脏辅助装置心室插管的体外评估。

• DOI: 10.1007/s13239-011-0050-x
• 发表时间: 2011
• 期刊: Cardiovascular engineering and technology
• 影响因子: 1.8
• 作者: Bachman,TimothyN;Bhama,JayK;Verkaik,Josiah;Vandenberghe,Stijn;Kormos,RobertL;Antaki,JamesF
• 通讯作者: Antaki,JamesF

Experimental verification of the feasibility of the cardiovascular impedance simulator.

• DOI: 10.1109/tbme.2009.2030498
• 发表时间: 2010-05
• 期刊: IEEE transactions on bio-medical engineering